Low-dose Acetylsalicylic Acid Before Non-cardiac Surgery

NCT ID: NCT03049566

Last Updated: 2017-03-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 805 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-02-10
• Study Completion Date: 2014-12-30

Brief Summary

This study aims to assess independent factors associated with the clinical decision to discontinue ASA preoperatively in patients undergoing elective non-cardiac surgery.

Detailed Description

Acetylsalicylic acid (ASA) is widely used for primary and secondary prevention of cardiovascular diseases. A prothrombotic rebound phenomenon after aspirin cessation has been reported. ASA withdrawal is associated with an increased incidence of adverse cardiac events. In individuals with previous percutaneous coronary intervention (PCI), cessation of ASA may cause stent thrombosis or myocardial infarction. However, many patients undergo non-cardiac surgery within the first two years after PCI. Perioperatively, two counteracting risks have to be taken into account, first, the risk of thromboembolic complications, if ASA medication is discontinued and second, the risk of surgical bleeding, if ASA therapy is continued. However, factors contributing to preoperative decision-making for ASA-withdrawal are still unclear.

This study aims to assess independent factors associated with the clinical decision to discontinue ASA preoperatively in patients undergoing elective non-cardiac surgery. In particular this study aims to determine if the presence of coronary stents is independently associated with ASA discontinuation. Furthermore this study assesses, if benefit-risk-estimates (numerical rating scales) of the patients and the supervising physicians are associated with the decision to withdraw ASA.

Study design

Patients on long-term ASA undergoing non-cardiac surgery as well as their supervising anesthesiologist participate in a preoperative survey. Detailed information about ASA medication, perioperative ASA use, comorbidities, factors that might be associated with the decision to discontinue ASA preoperatively and benefit-risk-estimates (numerical rating scales) are sampled by questionnaires.

Conditions

Surgery; Platelet Dysfunction

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

preoperative questionnaires

Patients on long-term acetylsalicylic acid undergoing non-cardiac surgery

preoperative questionnaires

Intervention Type: OTHER

no intervention, cross-sectional survey in a single group

Interventions

preoperative questionnaires

no intervention, cross-sectional survey in a single group

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 18 Years and older
• Scheduled for elective non-cardiac surgery
• Regular long-term ASA use, defined as daily low-dose (≤100mg) ASA therapy, even if ASA-medication was interrupted within the last 30 days before study inclusion

Exclusion Criteria

• < 18 Years
• No consent given

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christian Zöllner, Professor

Role: STUDY_DIRECTOR

Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf

Martin Petzoldt, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf

Locations

Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf

Hamburg, City state of Hamburg, Germany

Countries

Germany

Other Identifiers

WF03013

Identifier Type: -

Identifier Source: org_study_id